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DONEPEZIL HYDROCHLORIDE

ANDA

DONEPEZIL HYDROCHLORIDE | A078388 | CHARTWELL RX SCIENCES LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain24 active DMFs7 inactive

22 active API suppliers hold Drug Master Files for this ingredient.

FINETECH PHARMACEUTICAL LTDDONEPEZIL HYDROCHLORIDE

DMF 156942001

DR REDDYS LABORATORIES LTDDONEPEZIL HYDROCHLORIDE MONOHYDRATE (FORM-1) USP

DMF 177792004

JUBILANT BIOSYS LTDDONEPEZIL HYDROCHLORIDE USP (ANHYDROUS FORM-1)

DMF 190482005

SUN PHARMACEUTICAL INDUSTRIES LTDDONEPEZIL HYDROCHLORIDE USP

DMF 191292006

USV PRIVATE LTDDONEPEZIL HYDROCHLORIDE USP MONOHYDRATE

DMF 192862006

SYNTHIMED LABS PRIVATE LTDDONEPEZIL HYDROCHLORIDE MONOHYDRATE USP

DMF 199562006

APITORIA PHARMA PRIVATE LTDDONEPEZIL HYDROCHLORIDE USP, NON-STERILE DRUG SUBSTANCE

DMF 209092007

HETERO DRUGS LTDDONEPEZIL HYDROCHLORIDE (MONOHYDRATE)

DMF 210182007

TORRENT PHARMACEUTICALS LTDDONEPEZIL HYDROCHLORIDE USP

DMF 210192007

NEULAND LABORATORIES LTDDONEPEZIL HYDROCHLORIDE USP (FORM-I)

DMF 211322007

WOCKHARDT LTDDONEPEZIL HYDROCHLORIDE

DMF 219232008

ZYDUS LIFESCIENCES LTDDONEPEZIL HYDROCHLORIDE USP

DMF 222332008

MEGAFINE PHARMA P LTDDONEPEZIL HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 223792008

UNICHEM LABORATORIES LTDDONEPEZIL HYDROCHLORIDE MONOHYDRATE USP

DMF 226392009

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDONEPEZIL HYDROCHLORIDE USP

DMF 229012009

TAPI NL BVDONEPEZIL HYDROCHLORIDE

DMF 230772009

ALEMBIC PHARMACEUTICALS LTDDONEPEZIL HYDROCHLORIDE MONOHYDRATE USP

DMF 234262009

WAVELENGTH ENTERPRISES LTDDONEPEZIL HYDROCHLORIDE FORM III

DMF 240822010

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDONEPEZIL HYDROCHLORIDE USP

DMF 266052012

PIRAMAL PHARMA LTDDONEPEZIL HYDROCHLORIDE

DMF 276502014

HETERO DRUGS LTDDONEPEZIL HYDROCHLORIDE (ANHYDROUS)

DMF 291822015

CIPLA LTDDONEPEZIL HYDROCHLORIDE USP (ANHYDROUS)

DMF 308652016

VASUDHA PHARMA CHEM LTDDONEPEZIL HYDROCHLORIDE MONOHYDRATE USP

DMF 319762018

ZYDUS LIFESCIENCES LTDDONEPEZIL HYDROCHLORIDE USP (PROCESS-II)

DMF 433922025

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveDONEPEZIL HYDROCHLORIDE (MONOHYDRATE) USP

DMF 166742003

PERRIGO API LTDInactiveDONEPEZIL HYDROCHLORIDE (DILUTED) 25% AMORPHOUS

DMF 175232004

CIPLA LTDInactiveDONEPEZIL HYDROCHLORIDE FORM-I

DMF 184222005

APOTEX PHARMACHEM INDIA PVT LTDInactiveDONEPEZIL HYDROCHLORIDE MONOHYDRRATE USP

DMF 230082009

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveDONEPEZIL HYDROCHLORIDE (PROCESS II) USP

DMF 231782009

LUPIN LTDInactiveDONEPEZIL HYDROCHLORIDE USP

DMF 266622013

HIKAL LTDInactiveDONEPEZIL HYDROCHLORIDE API

DMF 276112013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 13, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Nov 26, 2010

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Nov 26, 2010